Delving into the Latest Updates on BEBT-209 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

BEBT 209, KCBT-0191

Target

CDK4 x CDK6

Action

inhibitors

Mechanism

CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Hormone receptor positive HER2 negative breast cancerAdvanced Triple-Negative Breast CarcinomaAdvanced breast cancer

Inactive Indication-

Originator Organization

BeBetter Med, Inc.

Active Organization

BeBetter Med, Inc.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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主要目的：评估BEBT-209联合系统化疗（卡铂和吉西他滨、白蛋白结合型紫杉醇或艾立布林）治疗晚期三阴性乳腺癌的安全性和初步疗效。次要目的：探索BEBT-209联合系统化疗治疗晚期三阴性乳腺癌的药效学与肿瘤组织表达PD-L1之关系。

[Translation]

Primary objective: To evaluate the safety and preliminary efficacy of BEBT-209 combined with systemic chemotherapy (carboplatin and gemcitabine, albumin-bound paclitaxel or eribulin) in the treatment of advanced triple-negative breast cancer. Secondary objective: To explore the relationship between the pharmacodynamics of BEBT-209 combined with systemic chemotherapy in the treatment of advanced triple-negative breast cancer and the expression of PD-L1 in tumor tissues.

Start Date03 Apr 2023

Sponsor / Collaborator

BeBetter Med, Inc.

NCT06998108

/ RecruitingPhase 3

A Multicenter, Randomized, Controlled, Double-blind Phase III Clinical Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant for the Treatment of HR+/HER2- Locally Advanced or Metastatic Breast Cancer in Patients With Disease Progression After Prior Endocrine Therapy

This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of BEBT-209 in combination with fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer.

Start Date09 Jun 2022

Sponsor / Collaborator

BeBetter Med, Inc.

[+1]

100 Clinical Results associated with BEBT-209

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100 Translational Medicine associated with BEBT-209

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100 Patents (Medical) associated with BEBT-209

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100 Deals associated with BEBT-209

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	Phase 3	China	BeBetter Med, Inc.	23 May 2022
Advanced Triple-Negative Breast Carcinoma	Phase 2	China	BeBetter Med, Inc.	03 Apr 2023
Advanced breast cancer	Phase 1	China	BeBetter Med, Inc.	15 Jul 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06685796 (BEBT-209, ASCO2025)	Phase 2	Metastatic Triple-Negative Breast Carcinoma	36	BEBT-209 + Gemcitabine and Carboplatin	mjoaeygcoj(faervoffoh) = lqdvmtliny ijgurpkdbq (zbzylhqurs, 13.9 - 68.4) View more	Positive	30 May 2025
NCT06685796 (NEWS) Manual	Phase 2	Metastatic Triple-Negative Breast Carcinoma	-	BEBT-209联合化疗 (辅助治疗后早期复发(12个月内复发))	hggbpkpoor(qqhihbtkzo) = aouwlokzon nsyueiskuk (baawqdwbgf ) View more	Positive	19 Dec 2024
NCT06685796 (NEWS) Manual	Phase 2	Metastatic Triple-Negative Breast Carcinoma	-	BEBT-209联合化疗 (接受过至少一线全身治疗的转移性TNBC患者)	hggbpkpoor(qqhihbtkzo) = dqhgflygbj nsyueiskuk (baawqdwbgf ) View more	Positive	19 Dec 2024